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Interpersonal RelationsSSGRIN-PGNCT01765166

Parent Treatment for Child Social Adjustment

A study testing SSGRIN-Parent Guide in people with Interpersonal Relations, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention [Social Skills GRoup INtervention (S.S. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Interpersonal Relations
What is being tested?
SSGRIN-Parent Guide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesUnited States
Study dates
Jan 2010to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Inclusion Criteria:children ages 8-12 experiencing peer difficulties who are English speaking. To confirm eligibility regarding peer difficulties, 3-C staff will conduct a brief (5 minute) phone-survey with parents for two sub-scales of the Social Skills Rating System: Parent Form (SSRS; Gresham \& Elliott, 1990). To be eligible for participation, a child must have a standard score either (a) less than one standard deviation (std) on the Social Skills Scale (<84%ile) or (b) greater than one std on the Problem Behavior Scale (>84%ile).

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Exclusion Criteria:SSGRIN group therapy is not recommended for extremely aggressive children (DeRosier, 2005), so any child scoring higher than two std on the Externalizing Problem Behavior Scale (>97%ile) will be excluded from participation and referral sources to other appropriate community resources will be given to parents.

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Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • 3-C Institute for Social Development

    Cary, North Carolina, 27513

  • Duke Child and Family Study Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Continuing the Research and Development of Parent Treatment for Child Social Adjustment

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal is to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations.

Read the detailed description

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal of this Competing Renewal is to conduct a rigorous, large-scale, longitudinal research project that is adequately powered to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations. Though schools often struggle with how to increase parent involvement in school-based programs, school officials report that it is infeasible for them to conduct the full series of in-person parent training groups as the Parent Guide's current curriculum demands; therefore, a second goal of this Competing Renewal is to test a Home-study version of the Parent Guide to bridge training into the home environment. The Home-study version of the Parent Guide will be included as a separate treatment condition within the effectiveness trial. This clinical trial will provide S.S.GRIN treatment for 240 children ages 8-12 and vary the level of parent intervention to determine the effectiveness of the two variations of Parent Guide to S.S.GRIN. Parents will be randomly assigned to one of four conditions: (1) Parent Guide treatment; (2) Parent Guide-Home Study treatment; (3) parent attention control; or (4) no treatment. Pre-treatment, post-treatment, 6-month post-treatment, and 12 month post-treatment data will be collected assessing children's social skill development from children, parents, and teachers. Based on past clinical experience, the probability of adverse psychological and behavioral effects from behavioral intervention is very low; however, to ensure participants' safety, a data and safety monitoring plan will be in place.

Being tested
SSGRIN-Parent Guide
Keywords
Social Skill Training, Social Interaction, Peer relations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSGRIN-Parent GuideBehavioural

    All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment. Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).

Study groups in NCT01765166
Study groupRoleWhat they receive
Control(ChO)ExperimentalChildren receive traditional SSGRIN child treatment with no parent involvement
Receives: Behavioral: SSGRIN-Parent Guide
Parent attention control(PAC)ExperimentalChildren will participate in traditional SSGRIN treatment, and parents will participate in a weekly support group to meet with other parents regarding their child's peer relations and behavior. The support group will meet for a parallel amount of time (1 hour/week for 10 weeks) and be facilitated by two parents with no SSGRIN or Parent Guide experience. The PAC condition will reflect the social support functions of a parenting group, but no therapeutic skills training or other instructional materials will be provided.
Receives: Behavioral: SSGRIN-Parent Guide
Parent Guide-Home Study(PG-HS)ExperimentalChildren will receive traditional SSGRIN treatment, and parents will receive the Parent Guide to SSGRIN training by participating in the online Parent Guide Home Study (PG-HS) course. The PG-HS course will include all instructional content and materials for the in-person Parent Guide course, but parent will receive the training online.
Receives: Behavioral: SSGRIN-Parent Guide
Parent Guide(PG)ExperimentalChildren will receive traditional SSGRIN treatment and parents will receive parallel traditional in-person SSGRIN-Parent Guide treatment.
Receives: Behavioral: SSGRIN-Parent Guide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Children's social skills

    Child Acquired Learning Questionnaire

    Measured: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment

Secondary outcomes (1)

  1. Parental, child, and dyadic behavioral observations

    Parent-child social problem solving assessment

    Measured: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2013 (estimated)
  2. Study startJan 2010
  3. Primary completionJan 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01765166
Sponsor's protocol ID
Pro00019396
Other IDs
2R44MH065718-04
Acronym
SSGRIN-PG
Status last verified
Jan 2013
First submitted
17 Dec 2012
Last updated
10 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • DeRosier ME. Building relationships and combating bullying: effectiveness of a school-based social skills group intervention. J Clin Child Adolesc Psychol. 2004 Mar;33(1):196-201. doi: 10.1207/S15374424JCCP3301_18.

    PubMed 15028553

  • DeRosier ME, Marcus SR. Building friendships and combating bullying: effectiveness of S.S.GRIN at one-year follow-up. J Clin Child Adolesc Psychol. 2005 Mar;34(1):140-50. doi: 10.1207/s15374424jccp3401_13.

    PubMed 15677288

  • DeRosier, M.E. & Gilliom, M. (2007). Effectiveness of a parent training program for improving children's social behavior. Journal of Child and Family Studies, 16, 660-670.

  • DeRosier, M.E. (1995). Summary of 3-C Program Results with 3rd through 5th graders in the WCPSS.

  • DeRosier, M.E. (2002). Group interventions and exercises for enhancing children's communication,cooperation, and confidence. Sarasota, FL: Professional Resources Press.

  • DeRosier, M.E. (2006). Social Skills Group Intervention - Parent Guide(S.S.GRIN-PG). Cary, NC: SELmedia,Inc.

Questions about this trial

What is this clinical trial studying?

A study testing SSGRIN-Parent Guide in people with Interpersonal Relations, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's social skills (time frame: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01765166, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.

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