Trial Outcomes & Findings for Parenting Strength At Home- Parents Pilot (NCT NCT03403153)

NCT ID: NCT03403153

Last Updated: 2024-07-26

Results Overview

The Client Satisfaction Questionnaire-8 (CSQ) assesses acceptability post-treatment. Eight items are scored on a 4-point scale inquiring about quality of services, treatment satisfaction, and willingness to recommend the treatment to others. Ratings are summed, with higher scores representing greater acceptability ratings (possible range 4-32). This measure is commonly used in both clinical trials and program evaluation, and has been shown to correlate with treatment attendance and outcomes. It takes approximately three minutes to complete. Evaluations of the measure found it to be reliable, with high coefficient alphas (.83-.93) to support internal consistency, and that it evidences positive construct validity with other measures of satisfaction. Where available, mean CSQ ratings can also be compared against norms from other studies in similar populations.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

91 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-07-26

Participant Flow

Recruitment was conducted between 3/01/2019 and 11/8/2019. Participants self-referred through study flyers or were recruited through letters sent to those veterans who met initial study eligibility based on medical record data.

Participants who were not retained at post-treatment cited logistical reasons for discontinuing in the study (e.g., work/school conflicts, travel time), and these participants mostly withdrew without attending any sessions.

Participant milestones

Participant milestones
Measure
SAHP Pilot
We aimed to recruit 20-32 participants across 2 male and 2 female (unyoked) pilot treatment groups. Although our recruitment target was partially constrained by pragmatic considerations, we believed that this sample size would allow us to test the feasibility of our recruitment methods and study procedures and give us sufficient quantitative and qualitative data on intervention reception. Ultimately, we recruited 12 female and 9 male Veterans.
SAHP Open Trial
Strength at Home - Parents (SAHP) is a trauma-informed psychotherapy group that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military veterans with post-traumatic stress disorder (PTSD) symptoms. SAHP was developed to maximize ease of use by VA providers and accessibility for parents.
Overall Study
STARTED
21
53
Overall Study
COMPLETED
20
47
Overall Study
NOT COMPLETED
1
6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parenting Strength At Home- Parents Pilot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SAHP Pilot
n=21 Participants
Strength at Home - Parents (SAHP) is a trauma-informed psychotherapy group that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military veterans with post-traumatic stress disorder (PTSD) symptoms. SAHP was developed to maximize ease of use by VA providers and accessibility for parents.
SAHP Open Trial
n=53 Participants
Strength at Home - Parents (SAHP) is a trauma-informed psychotherapy group that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military veterans with post-traumatic stress disorder (PTSD) symptoms. SAHP was developed to maximize ease of use by VA providers and accessibility for parents.
Total
n=74 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
21 Participants
n=99 Participants
53 Participants
n=107 Participants
74 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
28 Participants
n=107 Participants
40 Participants
n=206 Participants
Sex: Female, Male
Male
9 Participants
n=99 Participants
25 Participants
n=107 Participants
34 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
10 Participants
n=107 Participants
10 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=99 Participants
43 Participants
n=107 Participants
43 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
21 Participants
n=99 Participants
0 Participants
n=107 Participants
21 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
15 Participants
n=107 Participants
17 Participants
n=206 Participants
Race (NIH/OMB)
White
12 Participants
n=99 Participants
24 Participants
n=107 Participants
36 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
7 Participants
n=99 Participants
10 Participants
n=107 Participants
17 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
4 Participants
n=107 Participants
4 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: This measure given only in the Pilot trial.

The Client Satisfaction Questionnaire-8 (CSQ) assesses acceptability post-treatment. Eight items are scored on a 4-point scale inquiring about quality of services, treatment satisfaction, and willingness to recommend the treatment to others. Ratings are summed, with higher scores representing greater acceptability ratings (possible range 4-32). This measure is commonly used in both clinical trials and program evaluation, and has been shown to correlate with treatment attendance and outcomes. It takes approximately three minutes to complete. Evaluations of the measure found it to be reliable, with high coefficient alphas (.83-.93) to support internal consistency, and that it evidences positive construct validity with other measures of satisfaction. Where available, mean CSQ ratings can also be compared against norms from other studies in similar populations.

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=21 Participants
All participants in the open trial and pilot received the intervention.
Client Satisfaction Questionnaire-8 (CSQ; Attkisson & Greenfield, 2004)
29.9 score on a scale
Interval 4.0 to 32.0

PRIMARY outcome

Timeframe: 8 weeks

Population: Only participants in the pilot completed this measure

Measure was designed for this study and administered after each session to assess satisfaction with session components, overall session content, and homework. Sample questions include "The group exercise on child attachment was useful in understanding my child's behavior" and "The number of take home practice assignments is reasonable". Items are scored on a 9-point scale and averaged (range 0 - 8) with higher scores representing greater treatment satisfaction. Additional qualitative feedback was obtained using open-ended questions.

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=20 Participants
All participants in the open trial and pilot received the intervention.
Strength at Home Parents Specific Satisfaction Questionnaire
6.65 score on a scale
Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 8 weeks

Population: Those in the pilot completed this measure.

Measure was administered after first and last session to assess participants perspectives on whether the intervention was logical and their expectations for the success of the intervention. There are 4 items scored on an 8-point scale (range 0-32), with higher scores representing greater credibility, and a reported mean score of 24.96 in standardization samples. Although CEQ session ratings were used to guide manual revisions, only CEQ scores at pre and post-treatment were evaluated for this report. The CEQ has high internal consistency and test-re-test reliability (Devilly \& Borkovec, 2000).

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=20 Participants
All participants in the open trial and pilot received the intervention.
The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
1st session
27.7 score on a scale
Interval 0.0 to 32.0
The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
last session
28.9 score on a scale
Interval 0.0 to 32.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Open trial subjects

Measure has 120 items scored on a 5-point scale, yielding a parent domain score, a child domain scale measuring stress related to parent and child characteristics respectively. These scale scores are combined (Summed) to yield a parenting stress index total score with higher scores reflecting greater stress. The PSI has high reliability coefficients, internal consistency, and test-retest reliability. The measure has been validated for use in various populations (Abidin, 2012). The range for the total score is 20-100.

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=53 Participants
All participants in the open trial and pilot received the intervention.
The Parenting Stress Index, 4th Edition (PSI; Abidin, 2012)
Pre-treatment
62 score on a scale
Standard Deviation 8.95
The Parenting Stress Index, 4th Edition (PSI; Abidin, 2012)
post-treatment
55.5 score on a scale
Standard Deviation 7.95

SECONDARY outcome

Timeframe: 8 weeks

Population: open trial outcomes

Measure is a 12-item measure on a 4 - point scale measuring general family functioning. Items are averaged (range 1 to 4), with higher scores reflecting impaired family functioning. The FAD has high Cronbach's alpha (.86), and split-half reliability (.83) (Byles, et al., 1988). Consistency between responses to the 12-item FAD, and related family variables provides validity evidence.

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=53 Participants
All participants in the open trial and pilot received the intervention.
The Family Assessment Device General Family Functioning Scale (FAD; Epstein, Baldwin, & Bishop, 1983)
pre-treatment
2.17 score on a scale
Standard Deviation .5
The Family Assessment Device General Family Functioning Scale (FAD; Epstein, Baldwin, & Bishop, 1983)
post-treatment
1.86 score on a scale
Standard Deviation .6

SECONDARY outcome

Timeframe: 8 weeks

Population: open trial subjects

Measure is a 35-item measure on a 3-point scale assessing parents' impressions of their child's psychosocial functioning. Scores range from 0 to 70, with higher scores reflecting greater psychosocial problems and impairment. The PSC converges with the Child Behavior Checklist, an established self-report measures of child psychosocial difficulties (Jellinek et al., 1986).

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=53 Participants
All participants in the open trial and pilot received the intervention.
The Pediatric Symptom Checklist (PSC; Jellinek, et al., 1986)
Pre-treatment
20.6 score on a scale
Standard Deviation 8.06
The Pediatric Symptom Checklist (PSC; Jellinek, et al., 1986)
post-treatment
15.7 score on a scale
Standard Deviation 8.12

SECONDARY outcome

Timeframe: 8 weeks

Population: open trial subjects

Parental discipline practices were measured with the laxness and hostility subscales of the Parenting Scale (PS; Arnold et al., 1993). Scores are averaged with higher scores reflecting more dysfunctional parenting practices. Items are anchored by one effective and one ineffective discipline strategy rated on a 1 to 7 scale. The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline e.g. "If my child gets upset when I say 'no': I back down and give in to my child (1)… I stick to what I said (7)." The overreactivity scale measures use of emotional, harsh discipline such as "When my child misbehaves I spank, slap, grab, or hit my child... never or rarely (1) …. most of the time (7)." Adequate internal consistency and reliability have been demonstrated, and the scale correlates well with observational measures of dysfunctional discipline and child misbehavior (Arnold et al. 1993).

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=53 Participants
All participants in the open trial and pilot received the intervention.
The Parenting Scale Laxness Subscale
pre-treatment
2.68 score on a scale
Standard Deviation 1.14
The Parenting Scale Laxness Subscale
post-treatment
2.38 score on a scale
Standard Deviation .93

SECONDARY outcome

Timeframe: 8 weeks

Population: open trial subjects

Measure is a 21-item measure on a 4-point scale assessing depression symptom severity. Scores range from 0 to 63 with higher scores reflecting increased endorsement of depressive symptoms. The BDI-II has high internal consistency, good test-retest reliability (.94), and correlates highly with other interview-based measures of depression (Sprinkle et al., 2002).

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=53 Participants
All participants in the open trial and pilot received the intervention.
Beck Depression Inventory-II (BDI-II; Beck et al. 1996)
Pre-treatment
27.6 score on a scale
Standard Deviation 13
Beck Depression Inventory-II (BDI-II; Beck et al. 1996)
Post-treatment
21 score on a scale
Standard Deviation 11.8

SECONDARY outcome

Timeframe: 8 weeks

Population: open trial subjects

Measure is a 20-item measure on a 5-point scale assessing PTSD symptom severity. Scores range from 0 to 80 with higher scores reflecting increased endorsement of PTSD symptoms. The measure has good internal consistency, test-retest reliability and convergent and discriminant validity (Blevins, et al., 2015). The PCL-5 is as sensitive to clinical change that occurs between pre-and post- treatment as golden standard interview-based measures of PTSD symptoms (Worthmann et al., 2016).

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=53 Participants
All participants in the open trial and pilot received the intervention.
PTSD Checklist for DSM-5 (PCL-5; Weathers et al. 2013)
pre-treatment
44.1 score on a scale
Standard Deviation 16.1
PTSD Checklist for DSM-5 (PCL-5; Weathers et al. 2013)
post-treatment
35.5 score on a scale
Standard Deviation 17.8

SECONDARY outcome

Timeframe: 8 weeks

Parental discipline practices were measured with the laxness and hostility subscales of the Parenting Scale (PS; Arnold et al., 1993). Scores are averaged with higher scores reflecting more dysfunctional parenting practices. Items are anchored by one effective and one ineffective discipline strategy rated on a 1 to 7 scale. The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline e.g. "If my child gets upset when I say 'no': I back down and give in to my child (1)… I stick to what I said (7)." The overreactivity scale measures use of emotional, harsh discipline such as "When my child misbehaves I spank, slap, grab, or hit my child... never or rarely (1) …. most of the time (7)." Adequate internal consistency and reliability have been demonstrated, and the scale correlates well with observational measures of dysfunctional discipline and child misbehavior (Arnold et al. 1993).

Outcome measures

Outcome measures
Measure
SAHP Pilot
n=53 Participants
All participants in the open trial and pilot received the intervention.
Parenting Stress Index Hostility Subscale
pre-treatment
2.35 units on a scale
Standard Deviation 1.25
Parenting Stress Index Hostility Subscale
post-treatment
1.86 units on a scale
Standard Deviation .94

Adverse Events

Pilot Trial

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Open Trial

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Pilot Trial
n=21 participants at risk
All Participants will complete the 8-week parenting support intervention and will provide satisfaction and acceptability ratings of the intervention. In the pilot trial, participants will make these ratings after each session, in the open trial the ratings will be made pre and post intervention.
Open Trial
n=53 participants at risk
All Participants will complete the 8-week parenting support intervention and will provide satisfaction and acceptability ratings of the intervention. In the pilot trial, participants will make these ratings after each session, in the open trial the ratings will be made pre and post intervention.
Psychiatric disorders
Serious, anticipated, unrelated adverse event
0.00%
0/21 • Two months.
1.9%
1/53 • Number of events 1 • Two months.

Other adverse events

Adverse event data not reported

Additional Information

Dr, Suzannah Creech Ph.D

Department of Veterans Affairs

Phone: 254-297-3025

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place